Regulatory Affairs Officer 1 - CMC Specialist - Office based, Reading, UK - (R1026557) in Reading, UK at IQVIA™

Date Posted: 5/28/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    At least 1 year(s)
  • Date Posted:
    5/28/2018
  • Job ID:
    R1026557

Job Description

Join us on our exciting journey!

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE

Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects.

RESPONSIBILITIES

• Acts as a Regulatory Team Leader on small, straightforward regulatory projects and/or becomes involved in a small single service project, under the guidance of senior staff.

• Identifies project needs, tracks project timelines, implements client requests and manages day-to-day workload in collaboration with senior staff, as appropriate.

• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.

• Actively participates in project teams with internal and external customers independently and communicates confidently in straightforward matters.

• Understands the Scope of Work, deliverables and management of budget for any given project.

• May prepare slides and background material for small, straightforward business development meetings under senior guidance and present to clients at bid defence meetings by phone or in person.

• May prepare and deliver training, as appropriate.

• Performs other tasks or assignments, as delegated by Regulatory management.



Job Requirements

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate

Good, solid interpersonal communication (oral and written) and organisation skills

Strong software and computer skills, including MS Office applications

Demonstrates self-motivation and enthusiasm

Ability to work on several projects, with direction from senior staff as appropriate

Ability to follow SOPs consistently; provides independent thought to assist in process improvements

Ability to make decisions on discrete tasks under senior supervision

Ability to establish and maintain effective working relationships with co-workers, managers and clients

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

• Degree in life science-related discipline or professional equivalent plus at least 1 year relevant experience* or high school diploma plus at least 5-7 years experience* (*or combination of education, training and experience)

PHYSICAL REQUIREMENTS

Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Extensive use of keyboard requiring repetitive motion of fingers

Regular sitting for extended periods of time

Travel will be required

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.



Job ID: R1026557